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Opening Statement to the Standing Committee on Health

Health Canada—Regulation of Medical Devices

(Chapter 2 - March 2004 Report of the Auditor General)

29 April 2004

Sheila Fraser, FCA
Auditor General of Canada

Madam Chair, thank you for the opportunity to discuss the results of our audit of Health Canada's Medical Devices Program, Chapter 2 in the March 2004 Report. With me today is Linda Anglin, the Director responsible for this audit.

The federal government, as federal regulator, has a legislated responsibility that is outlined in the Food and Drugs Act to protect the health and safety of Canadians. Protecting Canadians from risks related to medical devices is the responsibility of Health Canada under the Act and the Medical Devices Regulations.

The goal of Health Canada's Medical Devices Program is to ensure that medical devices available in Canada are safe, effective, and of high quality. Health Canada has developed a regulatory framework to assess the safety and effectiveness of medical devices through a balance of quality system requirements, pre-market activities, and post-market activities.

Medical devices play an important role in the delivery of health care. They include diverse products such as surgical masks, blood test kits, diagnostic imaging equipment, joint implants, and heart valves. Modern health care relies more and more on these devices to diagnose, treat, mitigate, and prevent diseases and certain medical conditions. Canadians spend $5 billion on medical devices annually.

Our audit examined how the department manages the risks and benefits related to medical devices, whether it identifies weaknesses in the Program and takes action to address them, and measures and reports the results achieved by the Medical Devices Program.

In conducting our audit, we reviewed the 1992 report issued by the Medical Devices Review Committee and the Development Plan for an Improved Medical Devices Regulatory Program prepared by Health Canada in response to that report. We also reviewed documents from consultations with stakeholders that took place before the introduction of the Medical Devices Regulations. We examined Health Canada's activities to carry out its responsibilities. We made comparisons with the medical devices programs in the United States and the United Kingdom and Health Canada's Drug Program. Finally, we considered the impact of the Medical Devices Program's human and financial resources on Health Canada's ability to adequately carry out its responsibilities.

While Health Canada has made progress in important aspects of managing risks related to medical devices before they are authorized for sale, we concluded that it needs to better monitor the continued safety of medical devices once they are in use. We found that as a result of gaps in its Medical Devices Program, the Department does not have a comprehensive program to protect the health and safety of Canadians from risks related to medical devices, even though it committed to such a program over a decade ago. Its failure to deliver such a program compromises Health Canada's ability to protect health and safety, which could translate into a growing risk—risk of injury and liability.

More specifically, our audit found that Health Canada requires a more proactive inspection program once products are on the market to verify compliance with the Medical Devices Regulations. It needs a better approach to managing risks related to the sale of unlicensed medical devices.

Health Canada also needs to improve its post-market surveillance system to provide timely, accurate, and complete information about adverse events after devices are in use and once safety concerns are identified, they must be better communicated to those who need this information.

Further, the Department needs to address the risks posed by the reuse of single-use medical devices.

Health Canada also needs to ensure that Canadians have timely access to all available medical devices. While it is important that Health Canada take the necessary time to properly evaluate a device for safety and therapeutic effectiveness, delays in authorizing licences deny Canadians timely access. As such, Health Canada needs to ensure that devices are authorized within the performance targets. The Department also needs to consider activities that would allow it to benefit from international regulatory co-operation.

Although Health Canada has been aware of the gaps and weaknesses in its Medical Devices Program for some time, it has made limited effort to address them. Limited financial and human resources and limited progress in advancing international regulatory co-operation prevent the Department from addressing these gaps and weaknesses. This, in turn, prevents it from delivering the Medical Devices Program as it is designed.

While elements of the Program are acceptable, significant shortfalls indicate that the current Medical Devices Program is not sustainable over the long term. It is expected that medical devices will become increasingly complex and that the medical devices industry will grow in size and importance. Gaps and weaknesses that exist raise concerns about how Health Canada will manage the Program in the future.

As a result, we recommended that Health Canada make a choice: either provide adequate human and financial resources to deliver the Program as designed, or redesign the Program and the Medical Devices Regulations to manage risks in a way that calls for fewer resources.

Madam Chair, I am pleased to report that the Department has accepted all of our recommendations. The Committee may wish to ask the Department about the specific actions it intends to take to address our recommendations as well as timelines for implementation. I encourage your committee to review Health Canada's progress by requesting regular updates from the Department and following up on any remaining gaps and weaknesses.

This concludes my opening statement. We would be pleased to answer any questions.